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Standardized Fecal Microbiota Transplantation for Ulcerative Colitis

NCT01790061 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2024-04-19

No results posted yet for this study

Summary

The gut microbiota is considered to constitute a "microbial organ" which has pivotal roles in the intestinal diseases and body's metabolism. Evidence from animal and human studies strongly supports the link between intestinal bacteria and inflammatory bowel diseases (IBD). Dozens of studies reported its efficacy in treatment of severe Clostridium difficile colitis. Preliminary studies using FMT for Ulcerative Colitis (UC), Crohn's diseases, irritable bowel syndrome (IBS) and constipation have also met with some success. This is an initial step into investigating the potential efficacy of standardized fecal bacteriotherapy through mid-gut (at least below duodenal papilla) for UC, the investigators propose to determine the efficiency and safety of FMT in a series of 500 patients with moderate to severe UC (Montreal classification).

Conditions

Interventions

PROCEDURE

Standardized FMT

Fecal microbiota transplantation by gastroscopy administration of fresh or frozen bacteria from healthy donor to the mid-gut or whole colon

DRUG

Traditional treatments

Medications

Sponsors & Collaborators

  • Air Force Military Medical University, China

    collaborator OTHER

  • The Second Hospital of Nanjing Medical University

    lead OTHER

Principal Investigators

  • Huijie Zhang, MD,PhD · The Second Afiliated Hospital of Nanjing Medical University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01790061 on ClinicalTrials.gov